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The purpose of this study is to assess the safety, tolerability and pharmacokinetics of ABT-122 in subjects with Rheumatoid Arthritis.
This is a phase 1, randomized, double-blind, placebo-controlled, multiple ascending dose study. Twenty-four subjects with Rheumatoid Arthritis will be selected to participate. Subjects will be randomized to receive either ABT-122 or placebo. ABT-122 or placebo will be administered as subcutaneous (under the skin) injections in three dosing groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Randomized 6 drug/2 placebo by group |
|
| Group 2 | Experimental | Randomized 6 drug/2 placebo by group |
|
| Group 3 | Experimental | Randomized 6 drug/2 placebo by group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABT-122 | Biological | Injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Adverse Events | Collect all adverse events at each visit | From date of first dose of ABT-122 until 42 days after the last dose of ABT-122 |
| Change in physical exam including vital signs | Blood pressure, pulse and body temperature | From date of first dose of ABT-122 until 42 days after last dose of ABT-122 |
| Change in clinical lab test results | Hematology, Chemistry, and Urinalysis | From date of first dose of ABT-122 until 42 days after the last dose of ABT-122 |
| Change in Electrocardiogram (ECG) results | ECGs done in triplicate | From subject's baseline (prior to subject's first dose) and up to 168 hours following the last dose of study drug |
| Determination of pharmacokinetic (PK) parameters | Cmax, Tmax, AUC, elimination rate constant and half-life | Prior to first dose up to 42 days after the last dose of ABT-122 |
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of anti-drug anti-bodies (ADA) of ABT-122 | Measurement of ADA | Prior to each dose and up until 42 days after the last dose of ABT-122 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Padley, MD | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 108655 | Lenexa | Kansas | 66219 | United States | ||
| Site Reference ID/Investigator# 107115 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28744796 | Result | Khatri A, Goss S, Jiang P, Mansikka H, Othman AA. Pharmacokinetics of ABT-122, a TNF-alpha- and IL-17A-Targeted Dual-Variable Domain Immunoglobulin, in Healthy Subjects and Patients with Rheumatoid Arthritis: Results from Three Phase I Trials. Clin Pharmacokinet. 2018 May;57(5):613-623. doi: 10.1007/s40262-017-0580-y. | |
| 28941216 | Derived |
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| Placebo |
| Biological |
Placebo Injection |
|
| Raleigh |
| North Carolina |
| 27612 |
| United States |
| Site Reference ID/Investigator# 118964 | Duncansville | Pennsylvania | 16635 | United States |
| Site Reference ID/Investigator# 100780 | Dallas | Texas | 75231 | United States |
| Fleischmann RM, Wagner F, Kivitz AJ, Mansikka HT, Khan N, Othman AA, Khatri A, Hong F, Jiang P, Ruzek M, Padley RJ. Safety, Tolerability, and Pharmacodynamics of ABT-122, a Tumor Necrosis Factor- and Interleukin-17-Targeted Dual Variable Domain Immunoglobulin, in Patients With Rheumatoid Arthritis. Arthritis Rheumatol. 2017 Dec;69(12):2283-2291. doi: 10.1002/art.40319. Epub 2017 Nov 8. |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000625317 | ABT-122 |
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